|
Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research.〔CLIA related (Federal Register and Code of Federal Regulation Announcements ), and the FDA's (Clinical Laboratory Improvement Amendments (CLIA) ). Accessed Nov. 14, 2015.〕 ==CLIA Program== In accord with the CLIA, the CLIA Program sets standards and issues certificates for clinical laboratory testing.〔(CLIA Program homepage )〕 CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information for: * diagnosis, prevention, or treatment of disease or impairment * Health assessments An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed. Per CLIA, each specific laboratory system, assay, examination is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the following seven criteria. A score 1 is the lowest level of complexity and a score of 3 indicates the highest level. Score 2 is assigned when the characteristics for a particular test are intermediate between the descriptions listed for scores of 1 and 3.〔(CLIA Categorization Criteria ) (December 2012)〕 Criteria for categorization: # Knowledge # Training and experience # Reagents and materials preparation # Characteristics of operational steps # Calibration, quality control, and proficiency testing materials # Test system troubleshooting and equipment maintenance # Interpretation and judgment Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA Program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and Certification Group, and the Division of Laboratory Services. The CLIA Program is funded by user fees collected from approximately 200,000 laboratories, most located in the United States.〔(CLIA Overview ) (March 2007)〕 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Clinical Laboratory Improvement Amendments」の詳細全文を読む スポンサード リンク
|